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Behind Closed Doors: IRBs and the Making of Ethical Research

In this socio-historical account of the US' federally mandated institutional review boards, or IRBs, Laura Stark begins by offering an ethnographic analysis of the "knowledge experts" who sit on the committees, whose often-controversial role has been to approve and review biomedical research involving humans. She ably highlights the dissonance between the independence and autonomy of experts and the supposed administrative objectivity and "democratic" nature of the IRBs as ethically "declarative bodies".

In the book's second part, Stark's historical account of the conception and early development in the 1950s and 1960s of the National Institutes of Health's clinical research committees, the forerunners of contemporary IRBs, feeds into a convincing demonstration that such dissonance has been a feature since their inception. More interestingly, she shows how, with the help of an administrative structure (and an actual administrator), a collective of independent and diverse knowledge experts become "rule experts"; part-time bureaucrats whose approval and "recommendations" transform research proposals that may be ethically acceptable into proposals that are ethically acceptable.

Her analysis points to the fact that this transformation is achieved through a variety of techniques. IRB discussions feature the "warranting" of judgements (not only on the basis of fact but also through appeal to private and professional experiences) and reasoning by analogy, leading to the development of precedents that strongly influence subsequent IRB decisions. However, while discussion proceeds on the basis of varied, sometimes idiosyncratic and always subjective perspectives, it nevertheless nearly always leads to consensus. This facilitates the writing of "third-person", "objective" and unappealable ethical judgements by IRBs, an end point that committee members clearly bear in mind during their deliberations. Thus, a central task of an IRB is the "objectification" of indeterminate, individual and subjective assessments through the production of determinate, consensus-based outputs written in neutral prose.

Although Stark does not confirm the worst fears of the IRBs' critics, she certainly provides some ammunition.

She shows how a committee's moral assessment of individual researchers can become intertwined with ethical analysis of the research per se through, for example, a concern with administrative details such as typographical errors and the logical consistency of the proposal as presented in an ethics application. Indeed, I have heard of cases where the researcher's appearance seems to have contributed to the ethical assessment of the research. This analysis echoes some of my own concerns with the decision-making of the UK's research ethics committees, or RECs, and while Stark offers no outright solutions - and certainly there are no easy answers - her work foregrounds some of the systematic difficulties in the committee approach to ethical review. She highlights the fact that "biomedical research ethics" and the IRB system exhibit an affinity of ethos with the natural sciences; it remains to be explored whether there is necessarily any lesser affinity between the IRB system and the ethos of the social sciences, but Stark opens up this possibility for further reflection.

One criticism of Behind Closed Doors is that the story ends abruptly. I expected the historical account offered in its second part to be followed by further sociological accounts of the kind offered in the first. Unfortunately, they did not appear, and I was left with the impression that this was a book of two halves rather than three movements. Nevertheless, alongside Zachary Schrag's 2010 work Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009, this is one of the most important books concerned with the governance of research ethics, particularly in the social sciences, to have appeared in recent times. It deserves to be widely read by social scientists, applied ethicists who seek to comment on research ethics in the social and natural sciences and, perhaps most importantly, the academic and non-academic bureaucrats who are involved with the ethical governance of academic research.

Behind Closed Doors: IRBs and the Making of Ethical Research

By Laura Stark. University of Chicago Press. 240pp, £55.00 and £18.00. ISBN 9780226770864 and 0871. Published 7 February 2012